ISO GOST R ISO 14644

To pass the ISO GOST R ISO 14644
certification you need to call to expert-consulting center +7
(495) 640-41-21. Consultancy expert
will help you to select the most acceptable certification-system, will instruct you about the list of necessary documents, will give you contract,
will tell about the certification types, will accompany you till the moment of
receiving the certificate ISO GOST R ISO 14644.

Policies by the certification (from 3 to 30 days):

1.
Announce to
certification

2.
Making contract

3.
Acquisition of
documents

4.
Control and
analyze

5.
Conformity
certificate issuing

Common
information about certification ISO GOST R ISO 14644.

The
important document, which determines the profitability and competitive capacity of an enterprise in
future and in the near years, is the construction project of a new manufacture
or the project of it’s reconstruction. The project development is conducted
with account of requirements and European enactments: building regulations
(SNiP), GOST, non-departmental technological design standards (VNTP), EU
directive.

The
international GMP-standards come into account by the project development in the
aerospace, pharmaceutical, food and
microelectronic industry, and by the manufacturing of the diagnostic equipment,
foodstuff, active ingredients and accessory food substances. This type of
standards is obligatory in all mature
economies.

In
Russia, the analogue to GMP (Good Manufacturing Practice) in the “clean
space-room” sphere, are GOST R ISO 14644 standards, developed and accepted by
the technical committee ISO/TK 209 in 2002. GOST R ISO 14644 standards
determine the requirements to the cleanness of the space-rooms and, connected
to them., controlled environment in industrial activity branches, mentioned in
the preamble of this standard.

The
major factor at the plant, which can pollute the manufactured products, are the
operating personnel and the composition of the air, even under the compliance
with the veterinary sanitary requirements by the manufacturing, mentioned in
the parts 1-7 GOST R ISO and GMP, To
prevent this kind of pollution in manufacturing, will be realized the working
space zonation. The space should be divided under the special parameters in two
categories: “dirty” and “clean”. This zone-dividing is realized under the
conditions of contented aerosol
bacteria’s microparticles (microorganisms). The control of concentration of
microorganisms in air is conducted obligatory and is accomplished with help of
the space-constructions (the presence of the supply-extract system). Humidity,
temperature and pressure control may be conducted, if necessary. (ISO 14644-1)

The designing of the clean
room-spaces is to be made with account of requirements for this type of
manufacturing (GOST R ISO 14644). The temperature conditions, lighting, humidity, supply and exhaust
ventilation – all these parameters must conform the type of the room-space and
shouldn’t influence on the work of equipment.

Depending
on the purpose and stage of production, the clean room-spaces are divided into
rooms of the different cleanness-type classes. By designing of such kind of the
room, firstly, into account should be taken the logical order of manufacturing
operations and requirements, to minimize the cross-contamination and blending
of different components . For this goals are used the master manufacturing
control systems with the high-level intelligence.

The
main characteristics of the clean room-spaces are:

The control over the
concentration of the microparticles
(microorganisms) in the air;

The minimized inflow of
the microparticles in the environment;

The minimized evolution
of the microparticles;

The control over the
temperature, humidity and pressure;

The presence of the supply
and exhaust ventilation;

The providing of the ergonomic
parameters (Lighting, noise intensity).

The
classification of the clean room-spaces presents it’s class, which
characteristic is connected with the air cleanness-grade in the room. These
classification standards, depending on the industry branches, have the special
characteristics. For example, the concentration of the microorganisms is to be
inspected and rated in the food-manufacturing industry, pharmaceutics, in the
practical medicine. On the contrary, in the microelectronic manufacturing this
factor isn’t important. The classification of the clean room-space and it’s
class depend on the object’s state (according to GOST ISO 14644-1-2000) and are
determined by the microparticles concentration in the clean room-space or zone.
The clean room-spaces can be divided in three types:

As-built (the new-built
and newly reconstructed objects );

At- rest (completed
with the equipping;
smooth-running
operation );

Operational (the
manufacturing with the certain quantity of staff, conforming the
requirements and documents).

The
declared cleanness-level is observed by the fair number of the executed requirements, mentioned for each
clean room-space. These requirements are observed progressive.

ICO is able to:

Give a certificate of conformity to objects
passed the voluntary certification
in following certifications systems: ICO, GMP & CLEAN SYSTEMS and РОССТРОЙЗАЩИТА (Rosstroyzashita)

Suspend or
terminate the given certificates of conformity upon the existence of conforming
causes.

Among goals of ICO is spreading of quality-principles in organizations,
popularization of quality management-systems, knowledgeable assistance for organizations by
entering a new level of business dealing.